Working… Menu

A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061438
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : September 1, 2017
Information provided by:

Brief Summary:

This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems.

It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful.

This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication).

Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis.

It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis.

Approximately 240 patients will take part in this study.

Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.

Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Necrotizing Drug: meropenem Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis
Study Start Date : February 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
Drug Information available for: Meropenem

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of necrotizing pancreatitis within 120 hours following onset of symptoms/first reported symptoms.
  • Primary diagnosis to be confirmed by contrast-enhanced CT evidence of 30% necrosis of the pancreas.
  • Or if > or equal to 30% necrosis is not present or cannot be confirmed, a contrast enhanced CT scan showing extensive or multiple pancreatic fluid collections and pancreatic edema (Balthazar Grade E) with either C-reactive protein (CRP). 120 mg/L or a MOD score of > 2 is acceptable.

Exclusion Criteria:

  • Received an investigational drug or device within 30 days prior to entering study.
  • Received > 48 hours of antibiotic therapy between onset of symptoms of pancreatitis and diagnosis of necrotizing pancreatitis.
  • The subject has known or suspected anaphylactic or other type 1 (immediate) hypersensitivity reactions to cephalosporins, penicillins or carbapenems.
  • The subject is receiving, or will require, probenecid therapy.
  • The subject is neutropenic (absolute neutrophil count < 1000/mm 3).
  • The subject has cirrhosis, severity of Child's grade C.
  • There is not a commitment on the part of the clinical care team, the subject, or the subject's family to full, aggressive support including operative intervention if needed.
  • The subject is a pregnant and/or nursing female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00061438

Layout table for location information
United States, California
Research Site
San Francisco, California, United States
United States, Florida
Research Site
Tampa, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Research Site
Worcester, Massachusetts, United States
United States, New Jersey
Research Site
Newark, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, Washington
Research Site
Seattle, Washington, United States
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Layout table for investigator information
Study Director: AntiInfection Medical Science Director, MD AstraZeneca
Layout table for additonal information Identifier: NCT00061438    
Other Study ID Numbers: 3591IL/0089
First Posted: May 28, 2003    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Pfizer:
non-infected necrotizing pancreatitis
pancreatic infection
peripancreatic infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents